Capa Execution Specialist/Investigator (Medical Device Manufacturing)

Intellectt INCWilmington, DE

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Job Description

Job Title: CAPA Execution Specialist / Investigator Location: Delaware (Onsite)Employment Type: Contract (W2 / 1099)Duration: 12-month contract (possible extension up to 24 months) Job Summary:

The CAPA Execution Specialist is responsible for executing corrective and preventive actions within a medical device manufacturing environment. This role focuses on hands-on investigation, root cause analysis, and implementation of corrective actions on the manufacturing floor, ensuring compliance with FDA and ISO standards.

Responsibilities:

• Execute CAPAs end-to-end from investigation through closure• Perform root cause analysis using tools such as 5 Whys and Fishbone• Implement corrective and preventive actions on the manufacturing floor• Work closely with assembly teams to ensure adherence to procedures• Update SOPs, work instructions, and quality documentation• Support document control activities including procedural updates• Verify effectiveness of CAPAs and ensure sustainable solutions• Collaborate with Quality, Manufacturing, and Engineering teams• Manage multiple CAPAs in a fast-paced environment

Required Qualifications:

• Bachelor's degree in Mechanical, Biomedical, Quality Engineering, or related field• Hands-on experience executing CAPAs in medical device manufacturing• Strong knowledge of root cause analysis methodologies• Experience working on the manufacturing floor• Knowledge of FDA regulations and ISO standards• Experience with document control systems

Preferred Qualifications:

Experience with electromechanical assembly or capital equipment manufacturing Familiarity with Agile or hybrid document control systems Experience handling both manufacturing and system-level CAPAs

Salary:

The hourly rate for this position is US$40 $50 per hour.

Benefits:

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check:

Background checks may be conducted in accordance with applicable laws.

Work Authorization:

Applicants must be authorized to work in the United States.

If interested in this opportunity! Please send your resume to ahmed@intellectt.com or give me a call at +1-732-653-9472

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FAQs About Capa Execution Specialist/Investigator (Medical Device Manufacturing) Jobs at Intellectt INC

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This job at Intellectt INC is located in Wilmington, DE, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Intellectt INC?

Employer has not shared pay details for this role.

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